Kornimate/medical-research-clean huggingface dataset:
the role of dendritic cells in hepatitis c infection

Conditions: Chronic Hepatitis C Infection

Summary: the role of the dendritic cells, the most potent antigen presenting cells, in the establishment of chronic hepatitis c is not established. the study aims to define whether the dendritic cells are affected by the hepatitis c virus and whether that bears an impact on the antiviral immune response they generate. the hypothesis is explored by investigating a group of patients prior to and after the initiation of standard treatment for hepatitis c with pegylated interferon and ribavirin.


Eligibility criteria:
inclusion criteria: * anti-hcv positive * hcv rna positive exclusion criteria: * contraindications for antiviral treatment * concurrent chronic viral infections
recreational basketball to increase participation in diabetes prevention

Conditions: Type 2 Diabetes; PreDiabetes

Summary: the purpose of this study is to assess the efficacy of adapting the national diabetes prevention program (ndpp) to include recreational sports in effort to increase physical activity (pa) and promote lifestyle changes that can help reduce the risk of developing type 2 diabetes mellitus. the hypothesis is that both the traditional ndpp and the ndpp+ basketball will be considered feasible. the primary outcome is to assess whether the intervention (ndpp+bb) compared to the standard of care (ndpp only) will result in greater weight loss, lower a1c, and increased engagement in physical activity.

the ndpp has successfully helped to reduce the rate of type 2 diabetes mellitus (t2dm) through moderate weight loss and increased physical activity(pa). kaiser permanente georgia (kpga) members, identified as being at risk to develop type 2 diabetes will be recruited to participate in the intervention trial testing dpp vs. ndpp+ bb study arms. participants will be randomized into 1 of 2 groups (traditional dpp curriculum or dpp + basketball). the central objective of this project is to determine the feasibility of adapting the ndpp to include recreational basketball as an exercise component among kpga population of overweight, pre-diabetic adults ages 18-44 using novel translational science approach and qualitative formative research tools. the secondary objective is to implement the adapted ndpp + bb program among a pre-diabetic kpga adult members, 18-44 years living in atlanta and determine post-program efficacy in achieving the desired 5 percent weight loss goal. the objective is to contribute beneficial information to clinical and operational leaders across kp and beyond, as they consider approaches to improve overall participation rates in the ndpp, particularly for young and middle-aged adult members, leveraging interest in a popular recreational team-based sport such as bb. longer-term, the goal is to reduce diabetes risk.

Eligibility criteria:
inclusion criteria: * aged 18-44 years * bmi \>= 25 kg/m2 * previous diagnosis of prediabetes as defined: * hba1c 5.7 to 6.4% at baseline * not engaged in high exercise levels (self-report of less than 300 minutes of exercise per week) * not engaged in other lifestyle intervention program in past 2 years * ability to read in english and provide informed consent * ability to walk unassisted for 30 minutes * ability to jump in place exclusion criteria: * diabetes due to underlying conditions * type 1 diabetes * type 2 diabetes * end stage renal disease (esrd) * myocardial infarction within the last 12 months * cancer treatment * congestive heart disease * not currently pregnant * any history of seizures or uncontrolled neurologic or psychiatric condition that may interfere with the intervention plan

Keywords: prediabetes national diabetes prevention program weight loss physical activity basketball
cardiac allograft vasculopathy inhibition with alirocumab

Conditions: Vasculopathy

Summary: the focus of this study is to test the safety and efficacy of the pcsk9 inhibitor, alirocumab when administered early after heart transplantation (ht).the main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (cav) of alirocumab when given early after ht.


Eligibility criteria:
inclusion criteria: * heart transplant recipient exclusion criteria: * impaired liver function

Keywords: heart transplant
botulinum neurotoxin type a (bont-a) in paediatric non-neurogenic therapy resistant overactive bladder (oab)

Conditions: Overactive Bladder; Incontinence, Daytime Urinary; Incontinence, Nighttime Urinary

Summary: a non-intervention cohort study on the use of botulinum neurotoxin type a (bont-a) in paediatric non-neurogenic therapy resistant overactive bladder (oab). primary endpoint was the reduction of urinary incontinence.

the investigators wanted to cunduct an analysis of children with urinary incontinence who received intradetrusor injection of bont-a in the period 01.01.2016 to 31.12.2020 at their centre. all patients were refractory to standard urotherapy, anticholinergics, mirabegron and combination of treatments. patients with neurogenic bladder were excluded. primary endpoints were the effect on the frequency of urinary incontinence episodes. secondary endpoints included urodynamic parameters and uroflow characteristics in relation to side effects and response to treatment.

Eligibility criteria:
inclusion criteria: * oab * intradetrusor bont-a exclusion criteria: * neurogenic oab
effect of breathing a mixture of 92% oxygen (o2) + 8% carbon dioxide (co2) on flicker induced blood flow changes in ocular perfusion

Conditions: Flicker-induced Vasodilatation

Summary: it has been shown that diffuse luminance flicker increases retinal and optic nerve head blood flow. this indicates that a neuro-vascular coupling between neural activity and blood flow exists in the retina as described previously for the brain. although a lot of mediators such as no, po2, pco2, h+ and k+ have been proposed, the mechanism of this coupling is still a matter of controversy. however, it has been shown in an animal experiment, that an increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by decrease in po2 in the tissue. in a recently performed study we could show that breathing of 100% o2 did not influence flicker induced changes in the retina and optic nerve head. however, breathing of 100% oxygen also leads to a pronounced vasoconstriction of the retinal vessels and in turn to a increased tension of the vessel wall. recent evidence indicates that a combination of 92% o2 and 8% co2 can, at least partially, counteract the vasoconstrictory effect of o2 and increases tissue po2. thus, in this study the investigators set out to investigate the flicker light induced increase in blood flow under a mixture of o2/co2 .


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 35 years, nonsmokers * body mass index between 15th and 85th percentile * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropy \< 3 dpt. exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * blood donation during the previous 3 weeks

Keywords: retinal vessel diameter flicker-induced vasodilatation optic nerve head blood flow ocular physiology regional blood flow
dose response effects of inhaled fluticasone on airway effects of hypertonic-saline in asthma

Conditions: Asthma

Summary: this study investigates the effect of a inhaled corticosteroid (fluticasone or "flovent") on airway narrowing induced by hypertonic saline (salty water). the study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma exclusion criteria: * habitual cigarette smoking
effect of epidural opioid administered in the first a period on the progress of labour

Conditions: Anesthesia, Epidural; Opioid; Labor Pain

Summary: epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. the aim of the study is to compare different opioids administered in this early labour stage.


Eligibility criteria:
inclusion criteria: * parturient in labour without cervical dilation and regular uterine contractions exclusion criteria: * no consent * known allergy to administered opioid * contraindications to epidural analgesia * coagulopathies including platelet count of less than 100,000 * spine surgery in past
long-term follow-up of study participant treated with lentiviral-based genetically modified autologous cell product ,agt103-t

Conditions: HIV

Summary: long-term follow-up of study subjects who received agt103-t product in hiv study. the agt103-t is genetically modified cells that resist infection with hiv causing a depletion of hiv in hiv-infected study participants.

the primary objective of this study is to monitor study participant who receive the genetically modified gag specific cd4 t cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified cd4 t cells.

Eligibility criteria:
inclusion criteria: 1. received the investigational product, agt103-t, in the agt-sponsored agt-hc168 clinical trial 2. provided written informed consent, signed and dated by the study participant in the long-term follow-up study exclusion criteria: 1. did not receive the investigational product, agt103-t

Keywords: long term follow-up genetically modified cd4 t cells gene therapy lentivirus vector
effects of ly3848575 versus placebo in participants with painful distal sensory polyneuropathy

Conditions: Neuropathic Pain; Distal Sensory Polyneuropathy

Summary: the purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee. participation may last up to 30 weeks including screening.


Eligibility criteria:
inclusion criteria: * have a visual analog scale (vas) pain value ≥40 and \<95 at screening. * presence of painful distal sensory polyneuropathy (dsp) without prominent motor or autonomic features with gradual or insidious onset with a minimum duration of 6 months and a known cause of nerve injury, such as metabolic, toxic exposure, nutritional, immunologic, infectious, hereditary, multifactorial, or no known cause identified (idiopathic), of symmetrical nature and in lower extremities (with or without involvement of the hands). * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain- relieving therapies and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation. * are willing to discontinue all medications taken for chronic pain conditions, except the allowed pain medications. * individuals not of childbearing potential may participate in the trial. contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: * other etiologies of pain that may not be due to dsp or confound the assessment due to painful dsp. * have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest. * have not achieved glycemic control on a stable diabetes treatment regimen for at least 90 days prior to screening, have a healthcare provider who manages the participants' diabetes, and have a hemoglobin a1c (hba1c) \>11% at screening. * cancer within 2 years of baseline, except for: * cutaneous basal cell or squamous cell carcinoma resolved by excision, or * cancer treatment which led to chemotherapy that caused distal sensory polyneuropathy. * are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. * have a surgery planned during the study for any reason. * history of chronic alcohol, illicit drug, or narcotic use disorder within 2 years prior to screening.

Keywords: peripheral neuropathy diabetic peripheral neuropathy chemotherapy induced peripheral neuropathy hiv induced peripheral neuropathy
effect of neuromuscular blockade on pulmonary complications in elective cardiac surgery

Conditions: Neuromuscular Blockade; Postoperative Complications

Summary: the investigators will conduct a prospective, randomized trial to assess the impact of neuromuscular blockade on early (\<72 hours post-icu admission) postoperative respiratory complications in cardiac surgical patients. the study will compare continual neuromuscular blockade with cisatracurium to a single dose of succinylcholine during general anesthesia for cardiac surgery.

residual neuromuscular blockade during the immediate postoperative period is an important patient safety issue. although used to facilitate the technical performance of surgery, clinical studies have associated neuromuscular blockade (nmb) with increased incidence of postoperative respiratory complications. this effect is likely mediated by residual neuromuscular blockade interfering with airway tone and respiratory effort, leading to postoperative pneumonia, atelectasis or aspiration. however, the vast majority of these studies have involved non-cardiac patient populations, yet patients undergoing cardiac surgery are even more susceptible to the detrimental effects of residual neuromuscular blockade for a number of reasons. despite widespread utilization of paralysis during cardiac surgery, very little is known about residual neuromuscular blockade in patients following cardiac surgery. previously published clinical studies date from over a decade ago or are based on retrospective databases from non-cardiac surgery patients, precluding generalizable conclusions. given the substantial role of neuromuscular blockade in the traditional management of cardiac surgical patients, prospective data is needed to determine the veracity of this association as well as the surgical tolerability of protocols that minimize intraoperative paralysis. the investigators will conduct a prospective, randomized trial to assess impact of neuromuscular blockade on early (\<72 hours post-icu admission) postoperative respiratory complications.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery (cabg, valve replacement, cabg + valve) requiring cardiopulmonary bypass exclusion criteria: * emergency surgery * extremes of age * previous cardiac surgery * clinical contraindications to succinylcholine or cisatracurium * anticipated difficult tracheal intubation * preoperative mechanical ventilation * preoperative pharmacologic/mechanical hemodynamic support

Keywords: postoperative pulmonary complications residual neuromuscular blockade cardiac surgical procedures
an non-interventional study of patients with persistent symptoms of schizophrenia

Conditions: Schizophrenia

Summary: this multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.


Eligibility criteria:
inclusion criteria: patients: * adult patients, \>/= 18 years of age * diagnosis of schizophrenia according to diagnostic and statistical manual for mental disorders, 4th edition, text revision (dsm-iv-tr) or international classification of diseases, 10th revision (icd-10) caregivers: * age \>/= 18 years * family member or friend of the patient, who spends at least 4 hours a week with the patient exclusion criteria: * acute psychotic exacerbation in the 3 months prior to the baseline observation (e.g. hospitalization or increased psychiatric care in order to prevent hospitalization) * enrolled in an interventional study at the baseline observation
sophie pilot implementation and assessment

Conditions: Depression Chronic; Advanced Cancer; Anxiety

Summary: evidence-based interventions using cognitive behavioral therapy (cbt) and self-management education have been demonstrated to effectively treat symptoms of depression and improve the quality of life in populations with chronic illness. research indicates that cbt is the most effective psychosocial treatment for depression; as effective as pharmacotherapy and as effective as adding another medication for patients who do not respond to one antidepressant alone. despite the existence of proven efficacious treatments for depression, however, fewer than half of patients for whom depression treatment is indicated receive the services they need. access barriers (i.e., transportation, insurance coverage), limited clinician availability (i.e., long waitlists, difficulty finding a provider), and competing (and time-consuming) medical priorities contribute to inadequate depression treatment for individuals with serious chronic illness. in this research the investigators will conduct a pilot randomized trial to compare results from implementation of two cbt strategies ihope and sophie.

a pre-implementation pilot study will be conducted with 20 adult patients diagnosed with advanced (stage 3 or 4) cancer who screen positive for moderate depression and are receiving care at the solomont center for hematology and medical oncology at boston medical center (bmc) with the following specific aims: 1. using the consolidated framework for implementation research (cfir) as a guide, design a pilot implementation strategy for introducing the sophie cbt system and ihope system into the clinical context of care (months 1-4) 2. conduct a pre-implementation pilot study with randomization of 20 cancer patients who screen positive for depression and/or anxiety into two arms with sophie cbt or ihope telemedicine (10 participants each) to: a) assess the feasibility, acceptability, and appropriateness of implementing the sophie cbt and ihope interventions in an ambulatory cancer treatment center and b) evaluate the potential impact of the sophie cbt and ihope interventions on measures of depression, anxiety, coping, and quality of life for cancer patients with comorbid depression (months 5-10)

Eligibility criteria:
inclusion criteria: * diagnosed with stage 3 or 4 cancer receiving care at solomont cancer center * gad score \>10 and/or positive screening for moderate to severe depressive symptoms (phq-8\>9). * comfortable using tablet, phone and computer * has telephone access * speaks english * lives in greater boston area exclusion criteria: * patients without the capacity to provide informed consent * ongoing substance use disorder * patients with schizophrenia and dementia

Keywords: cognitive behavioral therapy (cbt) sophie cbt ihope cbt consolidated framework for implementation research (cfir)
multi-academic center study of xofigo patients

Conditions: Prostate Cancer, Castration Resistant

Summary: the study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mcrpc) and assess overall survival (os) associated with treatment sequences involving radium-223 and chemotherapy. while clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mcrpc, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide. the specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mcrpc where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mcrpc. the secondary objectives are to describe the safety patterns of docetaxel use among mcrpc patients who received chemotherapy post radium-223.


Eligibility criteria:
inclusion criteria: * received at least one dose of radium-223 after mcrpc diagnosis * received at least one prescription or dose of chemotherapy for treatment of mcrpc exclusion criteria: - no documented visceral metastasis at initiation of radium-223

Keywords: prostate cancer bone metastases xofigo
a healthy volunteer study to evaluate reversibility of induced impairment of cognition

Conditions: Cognition

Summary: the purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or azd1446 as compared to placebo, as assessed by electroencephalogram (eeg) measures.


Eligibility criteria:
inclusion criteria: * bmi 18-30 * non-smoker for at least 4 weeks exclusion criteria: * any clinically relevant acute or chronic disease * hypersensitivity to scopolamine * history of substance abuse

Keywords: healthy volunteers eeg
study comparing weekly versus every 3 week chemotherapy in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.

the standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. one way is by giving the chemotherapy more often in smaller doses. this approach can be associated with fewer or less troubling side effects. some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.

Eligibility criteria:
inclusion criteria: * cytologic or histologic diagnosis of ovarian carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma, stage ic-iv * indication for chemotherapy * age \> 18 years * life expectancy of at least 3 months exclusion criteria: * previous or concomitant malignant malignancy (excluding adequately treated baso-or squamocellular carcinoma of the skin and carcinoma in situ of the cervix, and synchronous endometrioid carcinoma stage ib or less for the uterus, with ovarian tumor stage ii or higher) * performance status (ecog) \> or = 3. * previous chemotherapy * heart disease (congestive heart failure, myocardial infarction within 6 months from study entry, atrioventricular block of any grade, severe arrhythmias) * neutrophils \< 2000 x mm3, platelets \< 100000 x mm3 * inadequate renal function (creatinine \> or = 1.25 x normal values) or liver function (alt or ast \> or = 1.25 x normal values) * present or suspected hemorrhagic syndromes * inability to comply with protocol and follow-up * inability to access study site for clinical visits * refusal of informed consent

Keywords: quality of life weekly therapy neurotoxicity